Dose Finding, Efficacy and Immunological Response of IP-001 Following MWA or IRE for CRLM

Recruiting now · Phase 1/Phase 2

Conditions studied: Colorectal Cancer, Liver Metastases, Liver Metastasis Colon Cancer

In brief

The primary objectives of this phase I/II, prospective clinical trial, are to assess the optimal dose, efficacy, safety and immunological effect of ablation and intra-tumoral injection of a novel immuno-adjuvant (IP-001) for colorectal liver metastases (CRLM). The study consists of three parts, devided into two phases. Phase 1 is a dose-escalation study according to a classic '3+3' design, to identify the dose level at which IP-001 exhibits an acceptable level of toxicity following microwave ablation (MWA) of CRLM in refractory metastatic colorectal cancer (CRC) patients. Phase 2, part 1 and part 2 are performed simultaneously. In phase 2 part 1, a single arm study assesses the efficacy of IP-001 following MWA for CRLM for curative intent. In phase 2 part 2, a randomized, two-armed study assesses the efficacy and immunomodulation of IP-001 following two ablative modalities: arm A (MWA) and arm C (irreversible electroporation (IRE)) for CRLM in refractory metastatic CRC patients.

Key facts

Study ID: NCT06630624
Run by: M.R. Meijerink
People needed: 120
Starts: 2024-07-10
Expected to finish: 2031-08-01
Last updated by the study team: 2025-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Measurable metastatic CRC based on RECIST v1.1;
The primary tumor has been resected before study inclusion or the patient is asymptomatic with respect to the in situ primary tumor;
Last imaging ≤ 4 weeks prior to the on-study ablative procedure;
Age ≥ 18 years;
Eastern Cooperative Oncology Group (ECOG) performance status of no more than 1;
A life expectancy of at least 3 months at the time of inclusion;
Adequate bone marrow, liver, and renal function as assessed by laboratory tests. These results should be judged by the local investigator and should be conducted within 7 days prior to definite inclusion;
Written informed consent.

You may not qualify if…

Compromised liver function defined as warning signs of portal hypertension, INR \&gt; 1,5 without use of anticoagulants, bilirubin \&gt; x 1.5 Upper limit of normal range (ULN) ASAT \&gt;5.0 x ULN, ALAT \&gt;5.0 x ULN.
Compromised kidney function defined as eGFR \&lt;45 ml/min (using the Cockcroft Gault formula);
Active autoimmune disease requiring disease-modifying therapy at the time of screening or during the study period: i.e. \&gt; 10 mg prednisolone per day or other immunosuppressive therapy (e.g. methotrexate);
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results;
Known allergic reaction to shellfish, crabs, crustaceans, or any trial components;
Known history of HIV or active Hepatitis C or Hepatitis B infection;
Uncontrolled infections (\&gt; grade 2 NCI-CTC version 3.0); requiring antibiotics;
Pregnant or breast-feeding subjects; Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment;
Known allergy to contrast agent that cannot be adequately prevented;
Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study;
Major surgery or radiotherapy ≤ 3 weeks (7 days for single fraction of palliative radiotherapy) prior to the on-study ablative procedure;
Systemic therapy ≤ 4 weeks prior to the on-study ablative procedure;
CTCAE Grade ≥1 from all side effects of prior therapies or prior procedures at the time of inclusion.
Phase 1
Inclusion Criteria:
Progressive or stable metastatic CRC on CT-scan after at least 1 lines of standard of care systemic treatment. Standard of care systemic treatment will be defined and determined by the treating oncologist. A summary of standard of care systemic treatment for CRLM as used by the medical oncologists at Amsterdam UMC has been listed in Table 1. Patients can also be included if systemic treatment has to be terminated due to toxicity or when patients refuse (further) systemic treatment, or when patients are in a therapy break from systemic therapy as patients can continue with further systemic treatment one month after the study treatment;
At least 2 CRLM eligible for MWA with a minimum diameter of 1cm and a maximum diameter of 3cm and one (optional but not required) CRLM that will be left untreated and is eligible for biopsy;
No limitations on intrahepatic or extrahepatic disease;
Exclusion Criteria:
No additional exclusion criteria.
Phase 2 part 1:
Inclusion Criteria:
At least one CRLM and a maximum of three CRLM size ≤ 3 cm eligible for MWA with curative intent;
Additional unablatable CRLM should be resectable with a maximum of 10 additional CRLM;
Resectability and ablatability should be re-confirmed intra-operatively by US in case of combined/staged resection and ablation. Intra-operatively also full exploration for hepatic, peritoneal and regional lymph node metastases should be performed;

Where it is running

Amsterdam UMC - location VUmc — Amsterdam, North Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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